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U.S. Department of Health and Human Services

Class 2 Device Recall Trident Hemispherical Acetabular Shell

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 Class 2 Recall
Trident Hemispherical Acetabular Shell
see related information
Date Posted August 13, 2009
Recall Status1 Terminated on August 17, 2009
Recall Number Z-1685-2009
Recall Event ID 50097
Premarket Notification
510(K) Number
K013676 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - Product Code MEH
Product Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.
Code Information Product Number: 508-11-72J; Lot Number: 20282301.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.
Quantity in Commerce 2 units
Distribution Distributed to 2 Stryker branches.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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